- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02851420
Spectrometry of Cancerous Lesions of the Oral Cavity (SpectrORL1)
Interest of Spectroscopy in the Diagnosis of Cancerous and Precancerous Lesions of the Upper Airways (UA): Pilot Study
The detection of suspect lesions is based on the clinical examination of the oral cavity and pharyngolaryngeal endoscopy, but the examination to confirm the diagnosis is a pathology examination of the biopsy taken during the endoscopy. Taking the biopsy, however, can be difficult. On the one hand , it is an invasive procedure, and may engender complications, and on the other hand, certain modifications of the mucosa may be discrete, or not particularly specific or, on the contrary, disseminated or extremely widespread.
Non-invasive tools to help the diagnosis could prove to be particularly interesting 1) to restrict the use of biopsies to patients in whom it is really necessary 2) and to identify the area where the biopsy should be done in cases of multiple lesions. In this context, spectroscopy could be a promising alternative.
The investigator puts forward the hypothesis that cancerous and precancerous lesions of the mucosa of the upper airways and digestive tract present a characteristic spectrometric profile. Indeed, as malignant tumours are hypervascularized and as precancerous tumours show signs of angiogenesis, investigators expect that the reflectance of haemoglobin will be diminished in the specific wavelengths of 540 and 575 nm, corresponding to the principal wavelengths absorbed by haemoglobin.
This pilot study will make it possible to construct an algorithm that could be used to classify lesions of the upper airways and digestive tract as either seemingly benign or cancerous.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dijon, France, 21079
- CHU Dijon Bourgogne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
patient - Patients consulting at the oto rhino laryngology department of Dijon for a functional symptom of the mouth, pharynx or larynx (pharyngeal discomfort, odynophagia, dysphagia, dysphonia, laryngeal dyspnoea) and in whom the clinical examination reveals a suspect lesion of the oral cavity, the pharynx or larynx and imposes an endoscopy procedure under general anaesthesia (unless it is a lesion of the tonsils or lingual tonsils)
- Subjects who have provided consent
- Subjects over 18 years old
volunteers:- Volunteers
- Absence of risk factors cancerous oro-pharyngeal lesions, that is to say, non-smokers, alcohol consumption < 1 glass per day.
- Absence of functional oto rhino laryngology symptoms (dyspnoea, dysphagia, dysphonia, pain)
- Subjects who have provided consent
- Subjects over 18 years old
Exclusion Criteria:
patient :- Patients without national health insurance cover
- Pregnant or breast-feeding women
Biopsies not feasible
- because of difficulty of exposure of the tumour
- tumour not accessible to the biopsy forceps,
- complications during the procedure making it impossible to do the biopsies (difficulties with ventilation)
Spectrometry not feasible
- If exposure is difficult, tumour not accessible to the spectrometry probe (for example, a hypopharyngeal tumour in a patient with limited mouth opening)
- In cases of anaesthesia complications, such as difficulties with ventilation
- Lesions of the tonsils or lingual tonsil, suggesting lymphoma (exclusion of lymphoid tumours)
volunteers:- Persons without national health insurance cover
- Pregnant or breast-feeding women
- Presence of risk factors: alcohol-smoking
- Presence of oto rhino laryngology functional symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: control
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Experimental: patient
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Reflectance spectrum of haemoglobin
Time Frame: Day one
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Day one
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FLAUS-BOZORG GRAYELI 2014
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Ohio State University Comprehensive Cancer CenterRecruitingTongue Cancer | Recurrent Squamous Cell Carcinoma of the Hypopharynx | Recurrent Squamous Cell Carcinoma of the Larynx | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Verrucous Carcinoma of the Larynx | Recurrent Verrucous Carcinoma of the Oral Cavity | Recurrent Adenoid... and other conditionsUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedMucositis | Tongue Cancer | Oral Complications | Recurrent Salivary Gland Cancer | Recurrent Squamous Cell Carcinoma of the Larynx | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Squamous Cell Carcinoma of the Oropharynx | Recurrent Verrucous Carcinoma of the Larynx | Recurrent... and other conditionsUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)TerminatedRecurrent Squamous Cell Carcinoma of the Hypopharynx | Recurrent Squamous Cell Carcinoma of the Larynx | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Squamous Cell Carcinoma of the Oropharynx | Recurrent Verrucous Carcinoma of the Larynx | Recurrent Verrucous Carcinoma... and other conditionsUnited States
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyWithdrawnTongue Cancer | Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity | Stage III Verrucous Carcinoma of the Oral Cavity | Stage IVA Verrucous Carcinoma of the Oral Cavity | Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity | Stage IVB Verrucous Carcinoma of the Oral Cavity | Stage IVA Squamous Cell Carcinoma of the Lip and Oral CavityUnited States
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Ohio State University Comprehensive Cancer CenterCompletedTongue Cancer | Salivary Gland Squamous Cell Carcinoma | Stage I Salivary Gland Cancer | Stage I Squamous Cell Carcinoma of the Hypopharynx | Stage I Squamous Cell Carcinoma of the Larynx | Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity | Stage I Squamous Cell Carcinoma of the Nasopharynx and other conditionsUnited States
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